NCT04127227

Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type

Sintilimab With P-GemOx (Pegaspargase, Gemcitabine and Oxaliplatin) Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type (ENKTL): a Single Arm, Open, Multicenter, Phase II Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)

Conditions

• NK/T Cell Lymphoma Nos

Interventions

Type	Name	Description
DRUG	sintilimab,pegaspargase,gemcitabine,oxaliplatin	All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimens their first-line therapy. Patients with CR or PR will receive sintilimab maintenance therapy

Timeline

• Start date: 2019-10-09
• Primary completion: 2023-07-20
• Completion: 2027-10-09
• First posted: 2019-10-15
• Last updated: 2026-03-03

Locations

1 site across 1 country: China